Phase 4
Completed N=16
Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation
Chronic Hypertension in Pregnancy
Source: ClinicalTrials.gov NCT02353806 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Area Under the Curve for Amlodipine in the Maternal Serum — 53.4 (hr*ng)/mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a phase IV prospective trial to collect and analyze information about the maternal pharmacokinetics of amlodipine besylate at the time of delivery and during postpartum lactation. The study will also evaluate amlodipine concentrations in the infants of breastfeeding mothers who are taking amlodipine besylate for treatment chronic hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve for Amlodipine in the Maternal Serum |
53.4 | — |
| PRIMARY Time to Maximal Concentration in the Maternal Serum. |
7.5 | — |
| PRIMARY Maximal Amlodipine Maternal Serum Concentration |
2.0 | — |
| PRIMARY Half-life of Amlodipine in Maternal Plasma |
13.7 | — |
| PRIMARY Clearance Rate of Plasma Amlodipine |
109.7 | — |
| PRIMARY Drug Levels/Concentration in Cord Blood (Amlodipine Levels/Concentrations) |
0.49; 1.27 | — |
| PRIMARY Amlodipine Concentration in Breastmilk |
NA | — |
| PRIMARY Drug Level/Concentration in Infant Blood (Amlodipine Level/Concentration) |
NA | — |
| SECONDARY Neonatal Birth Weight |
3281 | — |
| SECONDARY Infant Gestational Age at Delivery. |
38.2 | — |
| SECONDARY Infant Length of Stay. |
3.6 | — |
| SECONDARY Major Infant Complications |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years or older;
- Pregnant female
- Already taking amlodipine 5 mg for treatment of chronic hypertension in pregnancy;
- Hospitalized following routine term vaginal delivery or uncomplicated cesarean delivery
- Breastfeeding or breast and bottle-feeding their infant
Exclusion Criteria
- Known kidney disease
- Delivery complicated by chorioamnionitis, endometritis or postpartum hemorrhage
- Administration of greater than 5 mg of amlodipine in 24 hour period
Data sourced from ClinicalTrials.gov (NCT02353806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.